FDA Approves Pacira's Pain Drug Exparel

Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) said its drug Exparel, which is intended to treat pain following surgery, has been approved by the U.S. Food and Drug Administration. The company expects to launch Exparel in January 2012.

The FDA has approved Exparel, bupivacaine liposome injectable suspension, 1.3 percent for administration into the surgical site to produce post-surgical analgesia.

In a pivotal hemorrhoidectomy trial of Exparel versus placebo, where all patients with inadequate pain control received opioids for rescue pain relief, Exparel showed significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours, the company said.

Exparel (extended-release bupivacaine) for post-surgical pain management had a PDUFA deadline of Oct. 28. The approved indication is for single-dose infiltration into the surgical site to produce postsurgical analgesia, which is the broad label the company was seeking. Pacira expects to price Exparel at about $250 per procedure.

We anticipate that Pacira's initial launch strategy will focus on high-volume hospitals in the areas of soft tissue surgery, plastic surgery, and elastomeric bag replacement, with potential early pre-formulary approval sales from plastic surgeries, given it is generally an all-cash business, said Richard Lau, an analyst at Wedbush Securities.

To support the launch, the company expects to have data from both retrospective and prospective health outcome studies showing both the medical and economic benefits of Exparel treatment due to decreased opioid usage and opioid-related adverse events.

Through its agreement with Quintiles, Pacira Pharmaceuticals is hiring about 63 sales representatives who will cover about 81 percent of the target market.

Pacira ended third quarter with $37 million in cash which Lau estimates provides cash runway into the first quarter of 2012. He has modeled year-one Exparel sales of about $17.7 million with the assumption that hospital formulary adoption will take about 6 to 12 months.

Lau projects break-even at the end of 2013, full-year profitability in 2014, and peak gross U.S. sales of about $355 million in 2017. He raised his fair value estimate of Pacira Pharmaceuticals to $25 from $20, while reiterating his outperform rating.

Pacira stock is trading down 4.22 percent at $9.75 on the NASDAQ stock market at 9:30 am EDT.